HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of enalapril. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Angioedema: Angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) may occur with ACE inhibitors, including enalapril, although uncommonly. If you experience swelling of the face, tongue, or throat, you should stop taking Enalapril at once and get immediate medical attention. People who have had angioedema caused by other substances may be at increased risk of angioedema while receiving an ACE inhibitor such as enalapril.

Cough: People taking enalapril may develop a dry, persistent cough that usually disappears only after stopping or lowering the enalapril dose. Be sure to tell your doctor of any cough that does not seem to be related to a usual cause.

Diabetes: Enalapril may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Enalapril. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Enalapril may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Changes in kidney function have been seen in certain people taking Enalapril. The use of diuretics (water pills) or aliskiren may further increase the risk of kidney problems for those already at risk for this problem. If you have kidney disease, discuss with your doctor how Enalapril may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Enalapril, and whether any special monitoring is needed.

Liver function: Changes in liver function have occurred in people with or without preexisting liver problems during treatment with Enalapril. In most cases, the changes were reversed when the medication was stopped. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood pressure: Occasionally, blood pressure drops too low after taking enalapril. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur in those who take aliskiren, are on dialysis, are experiencing diarrhea or vomiting, are sweating excessively and not drinking enough fluids, have a salt-restricted diet, or are taking water pills. People with these conditions should be monitored closely by their doctor for the first weeks of treatment and whenever the dose of the medication is increased. To reduce the risk of dizziness, get up slowly from a lying down or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Excessive sweating and lack of fluid intake may lead to an excessive fall in blood pressure because of reduced fluid in your blood vessels. Vomiting or diarrhea may also lead to a fall in blood pressure. Consult your doctor if you feel your blood pressure is too low.

Potassium levels: Increases in blood levels of potassium occur for a small percentage of people taking enalapril. This rarely causes problems, but potassium levels should be monitored by your doctor. Avoid using salt substitutes that contain potassium while you are taking enalapril.

Pregnancy: ACE inhibitors such as enalapril may cause severe harm or death to the developing fetus if taken by the mother during pregnancy. Enalapril should not be used during pregnancy. If you become pregnant while taking Enalapril, contact your doctor immediately.

Breast-feeding: Enalapril passes into breast milk in small amounts. If you are a breast-feeding mother and are taking enalapril, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Enalapril have not been established for infants and children with decreased kidney function.

Seniors: Seniors have an increased risk of experiencing side effects when taking enalalpril due to reduced kidney function. Lower doses may be necessary to minimize side effects.